Registration Dossier
Registration Dossier
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EC number: 482-220-0 | CAS number: 848301-69-9
Endpoint summary
Administrative data
Description of key information
- Acute oral toxicity: The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight.
- Acute inhalation and dermal toxicity: Based on lack of skin irritation and systemic effects in a skin irritation study the substance is not considered to acute harmful in contact with skin. Moreover, the substance is unlikely to form aerosols or particles of inhalable size. Therefore it is considered justifiable not to conduct these studies.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Acute oral toxicity:
The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of OECD Guideline No 420 "Acute Oral Toxicity - Fixed Dose Method" and Method B1 bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC.
A dose level of 5000 mg/kg bodyweight resulted in no deaths, no signs of systemic toxicity, expected gains in bodyweight and no abnormalities at necropsy, in a total of 5 animals.
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight.
Acute inhalation and dermal toxicity:
No studies conducted on the test substance. However, based on lack of skin irritation and systemic effects in a skin irritation study the substance is not considered to acute harmful in contact with skin. The substance is unlikely to form aerosols or particles of inhalable size and therefore it is considered justifiable not to conduct inhalation study.
Justification for classification or non-classification
On the basis of the available oral, inhalation and dermal data, the substance does not require classification for lethal effects following a single exposure according to Regulation 1272/2008/EC.
Since the substance is composed of aliphatic hydrocarbons and certain grades of product are of low viscosity (product specification kinematic viscosity 3.0 and 4.0 cSt at 100°C), these may present an aspiration hazard in humans following oral exposure. It is therefore appropriate to classify these products as Aspiration Toxicity Category 1 according to Regulation 1272/2008/EC.
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